title: Investigation of emtricitabine-associated skin pigmentation and safety in HIV-1-infected Japanese patients.
abstract: Emtricitabine (FTC) has been reported to cause skin pigmentation (SP), and the incidence of SP associated with FTC varied with ethnicity, with a higher rate in African-American patients (8%). We assessed the incidence of SP in Japanese HIV-1-infected patients receiving combination antiretroviral therapy (cART) with FTC for a period of 48 weeks and confirmed new findings of FTC-associated SP, including pathological characteristics. This was a multicenter, prospective, longitudinal non-randomized study. We evaluated the appearance of SP at 48 weeks as the primary endpoint in 155 Japanese patients, and secondary endpoints included the characteristics of the SP (location, color tone, size, and progression). Six cases (3.9%) of SP occurred at a median of 124 days (range: 7-259 days) within 48 weeks. The SP looked like an isolated dark spot, 1-2 mm in diameter, mainly on the hands and/or feet. The severity of all the SPs was mild. Each SP had disappeared or faded at a median of 112 days (range: 28-315 days) with continued FTC. FTC-associated SP was considered to be lentigo simplex by dermatoscopy and pathological appearance. In summary, the incidence of FTC-associated SP in Japanese patients was 3.9%, and was comparable to the previously reported incidence in Asian patients (4%). FTC-associated SP was not associated with any clinically significant symptoms and has little clinical significance.
authors.affiliation: AIDS Medical Center, Osaka National Hospital, National Health Organization, 2-1-14 Hoenzaka, Chuo-ku, Osaka 540-0006, Japan. sirasaka@onh.go.jp
authors.forename: Takuma
authors.initials: T
authors.lastname: Shirasaka
authors.forename: Taketsugu
authors.initials: T
authors.lastname: Tadokoro
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Yamamoto
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Fukutake
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Kato
authors.forename: Takashi
authors.initials: T
authors.lastname: Odawara
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Nakamura
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ajisawa
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Negishi
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D046169:Dermoscopy; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006225:Hand; D006801:Humans; D015994:Incidence; D007564:Japan; D007911:Lentigo / Q000139:chemically induced / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010859:Pigmentation Disorders / Q000139:chemically induced* / Q000473:pathology; D011446:Prospective Studies; D012867:Skin / Q000187:drug effects / Q000473:pathology; D012880:Skin Pigmentation / Q000187:drug effects; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D003841:Deoxycytidine; D000068679:Emtricitabine